Effect of prehabilitation before total knee replacement on postoperative patient-reported joint awareness, enablement and knee function: protocol for the PROTEKT randomised controlled trial.

Up to 20% of patients remain dissatisfied after total knee replacement, partly due to poor preoperative function and unrealistic expectations.

• Knee osteoarthritis causes pain, reduced function and disability and may require total knee replacement.
• Poor preoperative function and unrealistic expectations are cited as contributing factors to dissatisfaction.
• Long waiting times for surgery may worsen patients' function prior to the procedure.
• Preoperative physiotherapy is rarely offered despite the potential waiting period.

The PROTEKT trial is a multicentre randomised controlled parallel-group trial designed to be conducted within two specialised orthopaedic outpatient rehabilitation units in the southeast healthcare region of Sweden.

• Eligible patients are aged 40–85 years and awaiting unilateral total knee replacement.
• Patients are randomised 1:1, stratified by age (≤67 and >67 years).
• A total of 110 patients will be recruited to the trial.
• Assessments are conducted at baseline, post-intervention, 1 week pre-surgery, and 6, 12, and 52 weeks post-surgery.

The prehabilitation intervention consists of 8 weeks of supervised exercise therapy and education twice per week, added to standard care.

• Exercise therapy includes strength, range of motion and balance components.
• Prehabilitation is delivered two times per week under supervision.
• The control group receives standard care alone.
• Standard care consists of self-care, a single standardised preoperative education session and standardised postoperative rehabilitation.

The primary outcomes of the trial are joint awareness measured by the Forgotten Joint Score-12 and patient enablement measured by the modified Patient Enablement Instrument-2.

• Secondary outcomes include patient satisfaction assessed via a 5-category Likert scale.
• Additional secondary outcomes include the Knee injury and Osteoarthritis Outcome Score, EuroQol 5 Dimension 3 Level questionnaire, and the International Physical Activity Questionnaire-short form.
• Objective function and accelerometer-based physical activity are also secondary outcomes.
• Analyses will follow intention-to-treat and per-protocol principles.

Statistical analyses will include between-group and within-group comparisons using t-tests or non-parametric equivalents, linear mixed models or generalised linear models, and multiple linear and logistic regression for predictor variable analysis.

• Sensitivity analyses will be performed to quantify the magnitude of missing data from patients lost to follow-up.
• Multiple linear regression will be used to analyse predictor variables for the primary outcomes.
• Logistic regression will also be used to analyse predictor variables for the primary outcomes.

The trial has received ethical approval from the Swedish Ethical Review Authority and is registered as NCT06290336.

• Ethical approval registration number is 2023-05120-01.
• The trial complies with the Declaration of Helsinki.
• Signed informed consent is collected for all patients before entering the trial.
• Results will be submitted for publication in a peer-reviewed journal and presented at international and national conferences.